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Arteriopathy and Endothelial Function

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00487617
First Posted: June 18, 2007
Last Update Posted: February 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Strasbourg, France
  Purpose
To determine whether fruit juice might reverse endothelial dysfunction and whether this reversibility has a prognosis value

Condition Intervention
Peripheral Arterial Disease Procedure: Fruit juice or placebo absorption

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endothelial Dysfunction Reversibility in Patients With Peripheral Arterial Disease

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Endothelial function 1 hour after taking the juice [ Time Frame: 1 hour after taking the juice ]

Secondary Outcome Measures:
  • Relationship between reversibility of the endothelial function and the patient's prognosis at 3 years [ Time Frame: 3 years ]

Estimated Enrollment: 50
Study Start Date: July 2007
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fruit juice
300 mL of fruit juice
Procedure: Fruit juice or placebo absorption
absorption of 300 ml of fruit juice ; 24 hours later, absorption of 300 ml of placebo.
Placebo Comparator: placebo
300 mL of fruit juice without polyphenols
Procedure: Fruit juice or placebo absorption
absorption of 300 ml of fruit juice ; 24 hours later, absorption of 300 ml of placebo.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Peripheral arteriopathy
  • Stable cardio-respiratory status

Exclusion Criteria:

  • Dialysis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00487617


Contacts
Contact: Olivier Rouyer, MD 33.3.88.11.61.22 olivier.rouyer@chru-strasbourg.fr

Locations
France
Service de Chirurgie Vasculaire Recruiting
Strasbourg, France, 67091
Contact: Fabien Thaveau, MD    33.3.88.11.60.68    fabien.thaveau@chru-strasbourg.fr   
Principal Investigator: Fabien Thaveau, MD         
Sub-Investigator: Nabil Chakfe, MD         
Sub-Investigator: Jean-Georges Kretz, MD         
Service de Physiologie et d'Explorations Fonctionnelles Recruiting
Strasbourg, France, 67091
Contact: Olivier Rouyer, MD    33.3.88.11.61.22    olivier.rouyer@chru-strasbourg.fr   
Principal Investigator: Olivier Rouyer, MD         
Sub-Investigator: Bernard Geny, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Study Director: Olivier Rouyer, MD Hôpitaux Universitaires de Strasbourg
  More Information

Responsible Party: Christine GEILLER, Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg
ClinicalTrials.gov Identifier: NCT00487617     History of Changes
Other Study ID Numbers: 3801
First Submitted: June 15, 2007
First Posted: June 18, 2007
Last Update Posted: February 25, 2009
Last Verified: February 2009

Keywords provided by University Hospital, Strasbourg, France:
Arteriopathy
endothelial function
fruit juice

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases